Teva Pharmaceutical Industries' US affiliate and partner Sanofi announced on Tuesday that a phase 2b study of Teva's investigational drug duvakitug for the treatment of ulcerative colitis and Crohn's disease met its primary endpoints. These two conditions are the most prevalent forms of inflammatory bowel disease. Data revealed that approximately 36% of patients receiving a low dose and 48% of those on a high dose exhibited clinical remission from ulcerative colitis, compared to just 21% on a placebo by week 14.
For Crohn's disease, 26% of low-dose patients and 48% of high-dose patients showed endoscopic response, while only 13% were observed with the placebo. The treatment effects were consistent across various subgroups, and duvakitug was reported to be 'generally well tolerated,' with no identified safety signals, as the companies indicated. Teva's Chief Medical Officer, Eric Hughes, remarked that the results have 'exceeded' their expectations.
Meanwhile, Sanofi's Head of Research and Development, Houman Ashrafian, described the outcomes as 'unprecedented.' Following the announcement, shares of Israel's Teva surged nearly 26% in late-afternoon trading, while shares of French drugmaker Sanofi experienced a jump of 7.4%. The companies plan to present detailed results at a scientific forum next year.
Currently, duvakitug is under rigorous clinical investigation, with its efficacy and safety yet to be evaluated by any regulatory authority, as stated by the firms. Teva and Sanofi are working together to co-develop and co-commercialize the drug intended for treating ulcerative colitis and Crohn's disease.
Development costs will be shared equally across the globe, along with net profits and losses in key markets, while a royalty arrangement applies in others. Teva will spearhead product commercialization in Europe, Israel, and select other regions, while Sanofi's focus will encompass North America, Japan, parts of Asia, and other global areas.
Sanofi is also set to lead a phase 3 clinical development program. The companies intend to initiate the phase 3 development for inflammatory bowel disease, contingent on regulatory discussions. Ashrafian stated, 'If the magnitude of effect persists in the phase 3 program, we believe we will have a differentiated medicine for (inflammatory bowel disease) patients who are in urgent need of new options.'.